Controlled Sedation for Cataract Surgery

Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03401606

Enrollment

Registered

2018-01-17

Start date

2014-11-01

Completion date

2016-01-30

Last updated

2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Conscious Sedation During Procedure

Keywords

sedation, dexmedetomidine, remifentanil, cataract surgery, surgeon satisfaction, patient satisfaction

Brief summary

This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

Detailed description

This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.

Interventions

DRUGremifentanil

remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished

DRUGDexmedetomidine

dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* subject has cataract, * subject older than 18 years, * local anesthesia and sedation.

Exclusion criteria

* general anesthesia, * history of consumption of sedatives.

Design outcomes

Primary

Measure	Time frame	Description
Surgeon and patient satisfaction	Intraoperative	It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges.

Secondary

Measure	Time frame	Description
Surgery duration	Intraoperative	Minutes
Heart rate	Intraoperative	Beats per minute (bpm)
Mean arterial pressure	Intraoperative	Millimeters of mercury (mmHg)
Hemoglobin oxygen saturation	Intraoperative	Oxygen saturation (%)

Other

Measure	Time frame	Description
Hypotension	Intraoperative	Systolic blood pressure below 90 mmHg
Respiratory depression	Intraoperative	Decreased respiratory rate below 10 rpm and desaturation, situation that required intubation
Oxygen desaturation	Intraoperative	Hemoglobin oxygen saturation below 90%
Internation	Intraoperative	Inpatient treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026